Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: HbA1c greater than or equal to 7.0 to lesser than 10.5 All patients must give written informed consent
Exclusion criteria
Exclusion criteria: Type 1 Diabetes mellitus Patients with a serum creatinine concentration greater than 132.6 mmol/L (1.5 mg/dL) or liver function impairment (AST and ALT 2.5 times upper limit of normal range) Patients have laboratory test abnormality (biochemistry, haematology, or urinalysis) Patients with significant alcohol, drug or medication abuse Currently under a psychiatrist s care or using antipsychotic or mood stabilizer medication or have diagnosed dementia or bipolar disorder or schizophrenia. Pregnant or lactating Had a documented CVD event (MI, stroke) in past 12 months Participation is purely voluntary and there will be no coercion by the consenter. Participants will not receive material compensation to join the study. All participants will be assured that they have the right to voluntarily withdraw from the study at any time and that withdrawal will not affect their future medical care. Participants will also be told that their diabetes care provider will be notified of their stress and depressive symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the cognitive status in patients with type 2 diabetes Improvement in cognitive function from baseline to 24 weeks Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Quality of life from baseline to 12 weeks Change in HbA1c from baseline to 24 weeks Change in BMI from baseline to 24 weeks Change in blood pressure from baseline to 24 weeks Change in other biochemical parameters from baseline to 24 weeksTimepoint: 24 weeks | — |
Countries
India
Contacts
Madras Diabetes Research Foundation